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Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

NCT ID: NCT01433107

Last Updated: 2013-12-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-02-29

Brief Summary

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This study will compare the efficacy and safety of a single dose of terbinafine film forming solution 1% with a single dose of placebo film forming solution in the treatment of tinea pedis.

Detailed Description

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Conditions

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Tinea Pedis

Keywords

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Tinea pedis Terbinafine film forming solution

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Terbinafine

Drug

Group Type EXPERIMENTAL

Terbinafine

Intervention Type DRUG

1% single application

Placebo

Drug

Group Type PLACEBO_COMPARATOR

Terbinafine Placebo

Intervention Type DRUG

single application

Interventions

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Terbinafine

1% single application

Intervention Type DRUG

Terbinafine Placebo

single application

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients ≥18 years of age with interdigital tinea pedis infection, with clinical diagnosis meeting required baseline total sign \& symptom score and positive microscopy

Exclusion Criteria

* Allergy to the allylamine class of antimycotics or excipients in the formulation.
* Chronic, hyperkeratotic plantar (moccasin) tinea pedis
* Other fungal disease or intertrigo
* Other abnormal findings on the affected foot
* Systemic antifungal or antimicrobial treatment within the last 3 months
* Topical treatment for skin lesions on feet within the last 3 months
* Diabetes mellitus and peripheral artery occlusive disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking University First Hospital

Beijing, , China

Site Status

Beijing University Hospital N°3

Beijing, , China

Site Status

The Second Affiliated Hospital of Sun Yat-sen University Guangzhou

Guangdong, , China

Site Status

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, , China

Site Status

Chinese Academy of Medical Sciences

Jiangsu, , China

Site Status

Huashan Hospital, Fudan University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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727-D-301

Identifier Type: -

Identifier Source: org_study_id